(70 days)
MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
MAQUET TRIOP VOLISTA® Surgical Light Systems have been developed in order to provide any operating room with LED technology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. The TRIOP VOLISTA® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations. The TRIOP VOLISTA® product family is composed by two different lightheads, Volista 400 and Volista 600. The System is available on ceiling versions and may be composed by one, two or three lightheads, which can be every possible combination of VOLISTA 400 and VOLISTA 600. Accessories such as integrated cameras and screen supports can be included to the TRIOP VOLISTA® Surgical Light System.
Here's an analysis of the provided text regarding the TRIOP VOLISTA® Surgical Light System, focusing on acceptance criteria and supporting studies:
This submission is for a surgical light system, which is generally a low-risk device. As such, the "acceptance criteria" and "studies" are primarily focused on compliance with recognized performance and safety standards rather than clinical efficacy studies often seen with diagnostic or therapeutic AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a surgical light), the "acceptance criteria" are embodied in compliance with established national and international standards for medical electrical equipment and surgical luminaires. The reported performance is the device's conformance to these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, Part 1: General Requirements for Safety, includes National Differences for USA) | Conformance to this standard is stated. |
| IEC 60601-2-41:2000 (Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires for diagnostics) | Conformance to this standard is stated. |
| IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Conformance to this standard is stated. |
| IEC 60601-1-2:2007 (General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Conformance to this standard is stated. |
| FCC Part 15 (10) Code of Federal Regulations, Title 47 Telecommunication, Chapter 1 - Federal Communications Commission, Part 15 - Radio frequency devices, Subpart B - Unintentional Radiators (Limits and methods of measurement of radio disturbance characteristics of information technology equipment) | Conformance to this standard is stated. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not detail a "test set" in the context of data-driven AI/ML models. For a physical device like a surgical light, the testing would involve validating prototypes or production units against the specified standards. The sample size would typically refer to the number of physical units tested to ensure design conformance, but this specific information (number of units tested) is not provided in the summary.
Data Provenance: Not applicable in the context of clinical or image-based data for an AI/ML device. The "data" here are the test results from physical evaluations of the device against engineering and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this submission. The "ground truth" for a surgical light is its ability to perform according to established engineering and safety standards. This is typically assessed through technical measurements and testing by qualified engineers and technicians, not clinical experts establishing a ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in studies where there is subjective interpretation (e.g., medical image reading) that requires expert consensus to establish ground truth. For a surgical light system's performance validation against standards, the results are typically objective measurements (e.g., light intensity, electromagnetic emissions, safety features), which do not require a subjective adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done.
MRMC studies are relevant for diagnostic or screening devices where human readers interpret medical data, and the study aims to assess the impact of an AI aid on their performance. This surgical light system is a physical device providing illumination, not an interpretive aid for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not Applicable.
This question refers to the performance of an AI algorithm operating independently. The TRIOP VOLISTA® Surgical Light System is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by the safety and performance requirements outlined in the referenced national and international standards (e.g., UL 60601-1, IEC 60601-2-41, IEC 60601-1, IEC 60601-1-2, FCC Part 15). The device is deemed acceptable if it meets these objective, measurable criteria. It is not based on expert consensus, pathology, or outcomes data related to disease diagnosis or treatment efficacy in the human body.
8. The Sample Size for the Training Set
Not Applicable.
This device is a physical product (surgical light), not an AI/ML system that requires a "training set" of data for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
As there is no AI/ML component or a "training set" for this device, the establishment of ground truth for such a set is irrelevant.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.